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Biotherapeutics (BioTD) Material Sciences is a scientific department within Discovery, Product Development & Supply (DPDS) and part of Janssen R&D. The department is responsible for: Application of science and risk-based approaches to the characterization and qualification of raw materials for the R&D and Supply Chain pharmaceutical product portfolio for monoclonal antibodies, conjugated monoclonal antibodies, radiopharmaceuticals, gene and cell therapies and vaccines including COVID-19; Identification of critical material attributes and control strategies for raw materials; In partnership with procurement and quality, plan and execute technical due diligence meetings and visits with raw material suppliers and contract manufacturing organizations (CMOs); Development of specifications and controls for cell culture media, buffers/chemicals, process chromatography resins, polymeric product contact materials including filters, bags and tubing, adjuvants and excipients; Investigation of complex material-related product and process deviations and manufacturing investigations
Main responsibilities include:
- In close collaboration with API and DP technical teams, formulate characterization plans to advance understanding of raw materials in manufacturing processes and formulations including, design, execution and/or lead experiments in support of raw material qualification
- Design and implement risk assessments for raw materials with suppliers and support internal efforts for identification and control of Critical Material Attributes
- Manage external contract labs on a day-to-day operational basis and direct development of methods, validation and transfer of methods to Contract Manufacturing Organization (CMO)or to Other Janssen Quality Control (QC) sites
- Lead analytical raw material projects independently with minimal guidance and can multi-task and manage several projects
- Point person for analytical team and ability to infer situation and present strategy slides and identify potential root cause in investigations
- Act as liaison between BioTD Material Sciences and other divisions within BioTD, DPDS and JSC and contribute technically to the project
- Ability to author sections related to raw materials in BLA’s and other global regulatory filings
- Support technology transfer and life cycle management of materials used in the clinical and commercial supply chain including technical assessment of supplier-initiated and Contract Manufacturing Organization (CMO)-initiated changes
- Lead investigations and present analytical options and solutions as part of bigger JSC lead team for commercial investigations
- Ability to develop bioassays, potency assays at external contract labs, direct validation protocol, execution and sign off on validation reports
- Perform inventory of vendors and status of raw material testing for management team and advise stakeholders on capacity management at contract labs
- Work with JRD procurement, contract lab board to qualify labs and provide inputs for MSA agreement for Material Sciences
- Work with BioTD finance and keep an active inventory of contract lab testing for various projects on a quarterly basis
- Support enhanced characterization and data analysis, e.g., latent variable statistical models
- Identify and coordinate analytical characterization with the internal and external labs and perform testing as applicable
- Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
- Ensure the proper and timely preparation of technical reports
- Participate in project and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations
- Ensure compliance with safety, GMP, quality and scientific principles
- A Bachelors in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 12 years of experience OR a Masters in Chemistry, Biology, Materials Science and Engineering, Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Pharmacy/Pharmaceutics or a related field with at least 9 years of experience OR Ph.D. with postdoctoral experience and at least 4-6 years of industrial experience is required
- Demonstrated proficiency in analytical assay method development especially with focus on SEC, Bioassay, ELISA, Peptide Mapping SDS-PAGE techniques including validation, and experience with technical transfers to other sites or contract labs is required.
- Demonstrated proficiency in Cytokine and Growth factor assays, immune checkpoint and T-Cell activation assays is preferred
- Demonstrated proficiency in small molecule & large molecule analytical assay method development for techniques including NMR, GC/MS, ELISA, SDS-PAGE, GC-HS, UPLC, LC/MS, other characterization techniques is required
- Prior experience with analytical characterization of chemically defined media and development of methods is preferred
- Demonstrated proficiency in understanding of various analytical instrument detection methods and techniques for cell and gene therapy raw materials is preferred.
- Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is strongly preferred
- Previous experience reviewing and authoring sections of BLA and supporting documentation and other regulatory filing is required
- Experience with developing analytical testing strategy for raw materials for global regulatory filing is required
- Demonstrated proficiency in strong written and verbal communication as well as project coordination with external parties, e.g., contract laboratories is strongly preferred
- Demonstrated competency and experience in use of project management tools (e.g., MS Project), spreadsheet and databases are preferred
- Demonstrated experience is lean and/or six sigma methodologies and tools is preferred
- This position will be based in Malvern, PA, US and may require up to 15% domestic travel post COVID-19 pandemic
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Research & Development, LLC (6084)